FLUDEOXYGLUCOSE F18 injection

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

FLUDEOXYGLUCOSE F-18 (UNII: 0Z5B2CJX4D) (FLUDEOXYGLUCOSE F-18 - UNII:0Z5B2CJX4D)

थमां उपलब्ध:

Memorial Sloan Kettering Cancer Center

INN (इंटरनेशनल नाम):

FLUDEOXYGLUCOSE F-18

रचना:

FLUDEOXYGLUCOSE F-18 300 mCi in 1 mL

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. None. Pregnancy Category C Animal reproduction studies have not been conducted with Fludeoxyglucose F 18 Injection. It is also not known whether Fludeoxyglucose F 18 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Consider alternative diagnostic tests in a

उत्पाद समीक्षा:

Fludeoxyglucose F 18 Injection is supplied in a multi-dose, capped glass vial containing between 0.740 – 11.1GBq/mL (20 - 300 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 29 mL.  The contents of each vial are sterile, pyrogen-free and preservative-free. NDC 69815-754-50 This radiopharmaceutical is licensed by the State of New York, Department Of Health, Bureau of Environmental Radiation Protection, for distribution to persons licensed pursuant to New York's Regulatory Code for Radioactive material specified in Chapter 1-Part 16 of the State Sanitary Code, as appropriate, or under equivalent licenses of an Agreement State or Licensing State. Store the Fludeoxyglucose F 18 Injection vial upright in a lead shielded container at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Store and dispose of Fludeoxyglucose F 18 Injection in accordance with the regulations and a general license, or its equivalent, of an Agreement State or a Licensing State. The expiration date and time are provided on the container label. Use Fludeoxyglucose F 18 Injection within 12 hours from the EOS time.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

FLUDEOXYGLUCOSE F18- FLUDEOXYGLUCOSE F18 INJECTION
MEMORIAL SLOAN KETTERING CANCER CENTER
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUDEOXYGLUCOSE F18 INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUDEOXYGLUCOSE F18 INJECTION.
FLUDEOXYGLUCOSE F18 INJECTION, FOR INTRAVENOUS USE.
INITIAL U.S. APPROVAL 2005
RECENT MAJOR CHANGES
Warnings and Precautions: ( 5.1, 5.2) 7/2010
Adverse Reactions ( 6) 7/2010
INDICATIONS AND USAGE
Fludeoxyglucose F18 Injection is indicated for positron emission
tomography (PET) imaging in the following settings:
Oncology: For assessment of abnormal glucose metabolism to assist in
the evaluation of malignancy in patients with
known or suspected abnormalities found by other testing modalities, or
in patients with an existing diagnosis of cancer.
Cardiology: For the identification of left ventricular myocardium with
residual glucose metabolism and reversible loss of
systolic function in patients with coronary artery disease and left
ventricular dysfunction, when used together with
myocardial perfusion imaging.
Neurology: For the identification of regions of abnormal glucose
metabolism associated with foci of epileptic seizures
(1).
DOSAGE AND ADMINISTRATION
Fludeoxyglucose F18 Injection emits radiation. Use procedures to
minimize radiation exposure. Screen for blood glucose
abnormalities.
In the oncology and neurology settings, instruct patients to fast for
4 – 6 hours prior to the drug’s injection. Consider
medical therapy and laboratory testing to assure at least two days of
normoglycemia prior to the drug’s administration
(5.2).
In the cardiology setting, administration of glucose-containing food
or liquids (e.g., 50 – 75 grams) prior to the drug’s
injection facilitates localization of cardiac ischemia (2.3).
Aseptically withdraw Fludeoxyglucose F18 Injection from its container
and administer by intravenous injection (2). The
recommended dose:
for adults is 5 – 10 mCi (185 – 370